AstraZeneca reports positive safety data for opioid-induced constipation drug

AstraZeneca has reported positive clinical trial data for naloxegol that highlights the strong safety performance of the promising peripherally-acting mu-opioid receptor antagonist.

Data from the Kodiac-08 trial demonstrated that naloxegol offered a better performance in terms of safety and adverse event (AE) rates among patients with non-cancer related pain and opioid-induced constipation than usual care methods.

A total of 534 patients received naloxegol once daily for up to 52 weeks and saw no increases from baseline levels in mean daily pain scores or mean total daily opioid dose, while there were no reports of opioid withdrawal AEs associated with the drug.

AstraZeneca plans to file for US and EU regulatory approval of the new product in the third quarter of 2013.

Dr Briggs Morrison, executive vice-president for global medicines development at AstraZeneca, said: "These high-level results are similar to the safety results seen in the phase III studies previously reported and provide further confidence in the data we’ve seen to date for naloxegol."

This comes after the company commenced an innovative adaptive trial of the promising new cancer drug AZD0424 last month, in association with Cancer Research UK.